Prenatal TMS for PTSD
Study Details
Study Description
Brief Summary
In this randomized clinical trial, we will test the feasibility, acceptability, and safety of repetitive transcranial magnetic stimulation (TMS) among pregnant participants with elevated symptoms of post-traumatic stress disorder and at increased risk to develop hypertensive disorders of pregnancy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is an unblinded ("open-label") RCT of TMS among 20 pregnant patients with elevated PTSD symptoms (PTSD Checklist for DSM-5 (PCL-5) score > 33) and at moderate to high risk to develop HDP based on American College of Obstetrician and Gynecologist guidelines. All participants will complete baseline and follow up clinical interviews and ultrasound assessments, weekly PTSD symptom assessments, and bi-weekly 24-hour blood pressure monitoring. Participants randomized to TMS will undergo a standard course of TMS treatment (30 sessions/6 weeks). Eligible participants will be randomized to a clinical TMS treatment course or usual care on a 1:1 ratio. The TMS protocol is designed to maximize clinical benefit and minimize risks (stimulation of right dorsolateral prefrontal cortex, 1Hz, 110% of motor threshold, 2400 pulses per session for thirty sessions, delivered after 14 weeks' gestation following completion of fetal organogensis). Throughout the intervention, all participants will complete biweekly 24-hour ambulatory blood pressure monitoring and weekly PTSD symptom assessments. HDP and HDP-associated outcomes will be measured by chart review after delivery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TMS Randomized participants will receive 30 sessions (5 days/week, 6 consecutive weeks) of active TMS to the right dorsolateral prefrontal cortex (DLPFC). Right DLPFC will be targeted using a modification of the Beam method (following Philip et al.). TMS will be administered at 1Hz, 110% of motor threshold, 2400 pulses per session |
Device: Transcranial magnetic stimulation
Participants randomized to TMS will undergo a standard course of TMS treatment (30 sessions/6 weeks). Eligible participants will be randomized to a clinical TMS treatment course or usual care on a 1:1 ratio.
|
| No Intervention: Usual care Participants randomized to usual care will continue to receive interventions for mental health symptoms and hypertension risk reduction. |
Outcome Measures
Primary Outcome Measures
- Feasibility of TMS for PTSD [Through study completion, on average 10 weeks]
Feasibility will be operationalized by TMS session completion.
Secondary Outcome Measures
- Safety of TMS in pregnancy [From the date of the first TMS intervention session through the end of participation, on average 10 weeks]
Adverse events will be recorded at every visit by asking participants to rate 10 symptoms (i.e., headache, itching, scalp pain) on a scale from 1-4 (1=absent, 4=severe, and whether the symptom was related to TMS. Vital signs will be checked before and after every TMS session. Fetal growth ultrasound studies will be performed before and after TMS treatment course.
Eligibility Criteria
Criteria
Inclusion Criteria:
- singleton pregnancy, English speaking, >18 years old, PCL-5 score of > 33 at enrollment, normotensive at enrollment, in stable psychiatric treatment (i.e., no change in medications or psychotherapy in the 6 weeks prior to enrollment), >13 weeks' gestation, and criteria consistent with 'moderate' to 'high' risk for preeclampsia
Exclusion Criteria:
- chronic hypertension; active suicidality or psychosis; bipolar I disorder; a seizure disorder and/or seizure disorder in a first degree relative; any metal object in the skull; fetal abnormality detected on anatomy scan; drug or alcohol abuse in the prior 6 months; history of preterm birth
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lifespan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1952743